Stimulation of the Rostral Zona Incerta for Parkinson's Disease

NCT ID: NCT03212885

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-03

Study Completion Date

2023-02-17

Brief Summary

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Patients with Parkinson's Disease who undergo Deep Brain Stimulation surgery receive symptom relief due to electrical stimulation of the brain. The target for the stimulation, in many cases, is the subthalamic nucleus (STN). The brain area just above the STN is called the rostral Zona Incerta (rZI). The rZI may be a potential target for deep brain stimulation, in combination with the STN.

Detailed Description

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Deep brain stimulation (DBS) of an area of the brain called the subthalamic nucleus (STN) is an effective treatment in Parkinson's disease (PD). However, stimulating the STN can lead to unwanted side effects that involve muscle movements (dyskinesias) and behavior and mood problems. DBS of a different brain structure, called the rostral zona incerta (rZI), has been demonstrated to be as effective as stimulating the STN, without any unwanted side effects in several studies. However, there is great variability in reported efficacy and adverse effects of rZI stimulation likely due to challenges in locating this area in the brain. The goals of this study are 1) to develop an improved method for targeting the rZI 2) determine efficacy of rZI with STN stimulation compared with STN stimulation alone, 3) evaluate any stimulation adverse effects of combined stimulation of the rZI and STN.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

STN Monopolar Stimulation

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.

2

rZI + STN stimulation

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.

Interventions

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Deep Brain Stimulation

Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Parkinson's Disease,
* No current deep brain stimulating electrodes

Exclusion Criteria

* Other movement disorders,
* Parkinson's Disease with already implanted electrode.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Drew S Kern, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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16-1443

Identifier Type: -

Identifier Source: org_study_id

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